Source of Hand Weakness After Stroke

This study has been withdrawn prior to enrollment.
(Methods unexpectedly required additional refinement that precluded subject enrollment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00907829
First received: May 21, 2009
Last updated: May 1, 2014
Last verified: May 2014

May 21, 2009
May 1, 2014
February 2009
January 2013   (final data collection date for primary outcome measure)
fingertip force [ Time Frame: force measured before and after intervention (1 week later) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907829 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Source of Hand Weakness After Stroke
Source of Neurally-Mediated Hand Weakness After Stroke

The purpose of this study is to determine whether neural block and neuromuscular electrical stimulation are effective in treating finger impairment due to stroke.

The incidence of stroke-induced hemiparesis among veterans is likely to rise as this population ages. Post-stroke hemiparesis is often marked by persistent hand impairment, which adversely affects both a person's ability to work and his/her quality of life. We believe that impairment is primarily due to neural, rather than biomechanical, factors. At the muscle level, these factors relate either to the inability to activate muscles (i.e., low muscle activation) or to activate them appropriately (i.e., abnormal muscle co-activation). Currently it is unclear as to which one is largely responsible for weakness in the hand as the net mechanical effect, e.g., reduced fingertip force production, could be the same. Determination of voluntary muscle force generation could help to explain deficits in fingertip force production in specific directions, as well as to customize treatment approaches in which force generation ability of some muscles is decreased and others increased. The goal of this work is to explain the source of neurally-mediated weakness at the fingertip following hemiparetic stroke, and to design and experimentally test rehabilitation interventions that attempt to offset this weakness.

As we were refining the protocol to experimentally test a rehabilitation intervention—involving neural block and stimulation of select muscles to decrease and increase muscle force generation—it was more challenging than anticipated to locate, using ultrasound, small nerve branches to individual muscles for selective neural blocking. As a result we designed additional interventions, using a computer model, that reflected the physical limitation to implementation which could still hopefully lead to improved fingertip function. We are seeking novel approaches to locate and block small nerve branches to individual muscles for an individual muscle-based approach to rehabilitation which we expect to be an improvement over rehabilitation interventions that target groups of muscles at a time. The clinical data collected in the study and biomechanical model simulation work provide guidance for a clinical trial study in the future.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Stroke
  • Cerebrovascular Accident
  • Drug: lidocaine
    comparison of the effect of the drug to help improve finger function
  • Device: muscle stimulator
    comparison of the effect of stimulated muscle(s) on finger function
  • Active Comparator: Arm 1
    persons with severe hand impairment following hemiparetic stroke
    Interventions:
    • Drug: lidocaine
    • Device: muscle stimulator
  • Active Comparator: Arm 2
    persons with severe hand impairment following hemiparetic stroke
    Intervention: Device: muscle stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of stroke;
  • stroke occurred no less than 6 months prior to study;
  • must have had only 1 stroke;
  • must demonstrate severe hand impairment;
  • must have no substantial evidence of motor and sensory deficits in non-paretic limb;
  • must have no history or clinical signs of neurologic diseases other than stroke;
  • must have no cognitive dysfunction that precludes comprehension of experimental tasks;
  • must be able to give informed consent

Exclusion Criteria:

  • taking medication that can increase the risk of lidocaine toxicity such as cimetidine (ulcer treatment drug), phenytoin (anticonvulsant drug), nadolol (drug for treatment of headache, hypertension, chest pain);
  • taking anticoagulant medication, i.e., aspirin, coumadin;
  • has a low platelet count or a bleeding disease
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00907829
B6302-W
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Joseph Towles Edward Hines Jr. VA Hospital
Department of Veterans Affairs
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP